Results of the prematurely terminated TEMPLE randomized controlled trial in patients with myelodysplastic syndrome: liberal versus restrictive red blood cell transfusion threshold

Jansen, A.J. Gerard; Bosch, Joan van den; Boekhorst, Peter te; Schipperus, Martin R.; Beckers, Erik A.M.

doi:10.1111/trf.15708

Cited by 9 publications

(7 citation statements)

References 6 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Of the 48 trials, 23 reported outcomes of fatigue or other QoL measures (Table 1). 10–30 Three additional RCTs reporting outcomes of fatigue or other QoL measures were identified in the updated search (Table 1). 31,32 Two trials were excluded because the scores for each arm were not available in a format that could be used for analysis, 33,34 and one trial was excluded for evaluating immediate versus delayed transfusion 35 …”

Section: Resultsmentioning

confidence: 99%

An analysis of quality of life and functional outcomes as reported in randomized trials for red cell transfusions

Pagano,

Dennis,

Idemudia

et al. 2023

Transfusion

View full text Add to dashboard Cite

BackgroundMeta‐analyses of randomized controlled trials (RCTs) evaluating thresholds for red blood cell (RBC) transfusion typically focus on mortality; however, other outcomes are highly relevant. The aim of this study is to summarize the effects of different transfusion thresholds on the outcomes of quality of life (QoL) and function.Study DesignWe extracted data from RCTs identified in a recently published Cochrane systematic review. Primary analysis was descriptive.ResultsA total of 23 RCTs with 13,743 adult participants were included. Fifteen RCTs included patients in the postoperative period, of which 9 RCTs were conducted in hip (n = 3024) and 6 (n = 8672) in cardiac surgeries; 5 RCTs (n = 489) were in patients with hematological malignancies; 2 in the setting of bleeding (gastrointestinal bleed [n = 936] and postpartum [n = 521]); and one RCT (n = 936) included critically ill patients. QoL and function were reported using a variety of questionnaires and tools. The timing of assessments varied between trials. No clear clinical differences in QoL outcomes were identified in comparisons between restrictive and liberal transfusion thresholds.DiscussionThere is no evidence that a liberal transfusion strategy improves QoL and functional outcomes. However, the substantial limitations of many included studies indicate the need for further well‐designed and adequately powered trials.

show abstract

Section: Resultsmentioning

confidence: 99%

An analysis of quality of life and functional outcomes as reported in randomized trials for red cell transfusions

Pagano,

Dennis,

Idemudia

et al. 2023

Transfusion

View full text Add to dashboard Cite

show abstract

“…There are some challenges in implementing this study. A previous transfusion study in MDS patients was terminated early due to poor recruitment 41 ; to mitigate this risk, study recruitment is open in multiple sites in three countries. The use of an n-of-1 study design also enables participants to act as both treatment and control, thus reducing the number of patients otherwise required in a randomized study.…”

Section: Discussionmentioning

confidence: 99%

Rethinking the transfusion pathway in myelodysplastic syndromes: Study protocol for a novel randomized feasibility n‐of‐1 trial of weekly‐interval red cell transfusion in myelodysplastic syndromes

Mo,

Wood,

Shortt

et al. 2024

Transfusion

View full text Add to dashboard Cite

BackgroundAnemia in myelodysplastic syndromes (MDS) is associated with poorer health‐related quality of life (HRQoL) and physical function, and is frequently treated with transfusions. The current common practice of transfusing multiple red blood cells (RBC) units every 2–4 weeks may result in peaks/troughs in hemoglobin (Hb) level, yet maintaining a stable Hb may better improve HRQoL. We describe a study protocol aiming to investigate the feasibility of weekly low‐dose RBC transfusion in MDS patients, including assessing HRQoL and physical function outcomes.Study Design and MethodsIn this n‐of‐1 pilot study, patients receive two treatment arms, with randomly allocated treatment sequence: arm A (patient's usual transfusion schedule) and arm B (weekly transfusion, individualized per patient). To facilitate timely delivery of weekly transfusion, extended‐matched RBCs are provided, with transfusion based upon the previous week's Hb/pre‐transfusion testing results to eliminate delays of awaiting contemporaneous cross‐matching. Primary outcome is the feasibility of delivering weekly transfusion. Secondary outcomes include HRQoL, functional activity measurements, RBC usage, and alloimmunization rates. A qualitative substudy explores patient and staff experiences.ResultsThe trial is open in Australia, Netherlands, and UK. The first patient was recruited in 2020. Inter‐country differences in providing RBCs are observed, including patient genotyping versus serological phenotyping to select compatible units.DiscussionThis pilot trial evaluates a novel personalized transfusion approach of weekly matched RBC transfusion and challenges the dogma of current routine pre‐transfusion matching practice. Findings on study feasibility, HRQoL, and physical functional outcomes and the qualitative substudy will inform the design of a larger definitive trial powered for clinical outcomes.

show abstract

“…To date, there have only been two small randomised controlled trials (13 and 38 patients) comparing restrictive versus liberal thresholds in chronic transfusion‐dependent patients. Although not adequately powered to detect clinically relevant differences, results are suggestive of an improved QoL with higher Hb‐levels [ 31 , 32 ]. Currently, several studies with chronic transfusion‐dependent patients are conducted (REDDS‐2, ACTRN12619001053112; REMOTE 2, NL9289; EnhanceRBC, NCT02099669; SMD‐Transfu, NCT03643042; PTQA, NCT03660228).…”

Section: Discussionmentioning

confidence: 99%

Clinical practice for outpatients that are chronically red cell dependent: A survey in the Netherlands

2021

Self Cite

View full text Add to dashboard Cite

Background and Objectives: Limited data are available to guide physicians on how to determine the red blood cell (RBC) transfusion regimen in chronically transfusiondependent patients. The lack of clarity on thresholds and targets to be used for transfusion could easily result in either under or over transfusion in these patients. The aim of our survey is to investigate (1) transfusion thresholds; (2) number of RBC units given per transfusion episode; (3) interval between transfusions and (4) patient factors, like decreased cardiac function modulating the former. Materials and Methods:We sent a web-based 44-question survey to members of the Dutch Haematology Association.Results: Fifty physicians responded between June and October 2020 (response rate 30%), well-distributed between community and academic hospitals. A wide variation in transfusion strategies was reported: Most patients have transfused 1-2 RBC units (range: 0-3 units) every 2-4 weeks (range: 1-12 weeks) with a median threshold of 8.0 g/dl ranging from 6.4 to 9.6 g/dl. Patient-specific clinical factors that are most frequently reported to influence the transfusion strategy are angina pectoris, cardiac failure and dyspnoea, softer parameters that are of influence are the quality of life and self-sustainability. Conclusion:The results of this survey indicate a broad variation in RBC transfusion strategies in Dutch patients with chronic transfusion dependency. While the current variation in transfusion strategies may be unavoidable in an individualized approach, randomized trials and better defined usable parameters to evaluate the effect of transfusion strategies are required to reach a consensus on how to determine the transfusion strategy.chronic anaemia, patient blood management, red blood cell transfusion, survey, transfusion dependency Highlights• Great variability in transfusion strategies for chronic anaemic patients was found.• Parameters associated with changes in transfusion strategies, like angina pectoris and selfsustainability, are identified.• The outcomes allows professionals to benchmark their transfusion strategies and practices and reflect on them, and can be used in training.

show abstract

Results of the prematurely terminated TEMPLE randomized controlled trial in patients with myelodysplastic syndrome: liberal versus restrictive red blood cell transfusion threshold

Cited by 9 publications

References 6 publications

An analysis of quality of life and functional outcomes as reported in randomized trials for red cell transfusions

An analysis of quality of life and functional outcomes as reported in randomized trials for red cell transfusions

Rethinking the transfusion pathway in myelodysplastic syndromes: Study protocol for a novel randomized feasibility n‐of‐1 trial of weekly‐interval red cell transfusion in myelodysplastic syndromes

Clinical practice for outpatients that are chronically red cell dependent: A survey in the Netherlands

Contact Info

Product

Resources

About